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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K933435
Device Name DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2
Applicant
Baxter Diagnostics, Inc.
P.O.Box 520672
Miami,  FL  33152
Applicant Contact ROSETTA GEFFEN
Correspondent
Baxter Diagnostics, Inc.
P.O.Box 520672
Miami,  FL  33152
Correspondent Contact ROSETTA GEFFEN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/14/1993
Decision Date 09/24/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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